Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70
OBJECTIVES:
Primary
- Determine the quality of life of older patients with locally advanced or metastatic
non-small cell lung cancer treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine the overall survival and progression-free survival of patients treated with
this drug.
- Determine the mood status and autonomy of activity of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6
courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6
and 12 months after completion of study treatment.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Quality of life
No
Pierre Fargeot, MD
Study Chair
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
United States: Federal Government
CDR0000443593
NCT00227708
June 2005
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